BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L

    MDR report key: 10117916 · Received June 4, 2020

    Report

    Report Number
    3005180920-2020-00306
    Event Type
    Injury
    Date Received
    June 4, 2020
    Date of Event
    May 5, 2020
    Report Date
    June 4, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826771
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 MAY 2020: LOT 179667: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2018. EXPIRATION DATE: 2023-03-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 12 MAY 2020: GMK-SPHERE 02.12.0026L FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ L (K140826) LOT. 1901878 LOT 1901878: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JUL-2019. EXPIRATION DATE: 2024-06-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT. 1905242 LOT 1905242: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2019. EXPIRATION DATE: 2024-11-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, THREE MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND PERFORMED A WASHOUT. A FEMORAL AND TIBIAL COMPONENT WERE IMPLANTED ALONG WITH ANTIBIOTIC CEMENT. THE SURGEON WILL IMPLANT PERMANENT HARDWARE AT A LATER DATE THAT HAS YET TO BE DETERMINED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582096 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0512FL 179667 07630030826771

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention